Diabetes testing kits are urgently recalled amid fears they give false readings and could put lives at risk
- Strips Accu-Chek Aviva and Accu-Chek Performa may give false readings
- The MHRA estimates more than 260,000 packs have been affected
- Could mean patients over or under dose, leading to serious consequences
- Patients should return their strips to their pharmacy for a replacement
Diabetes testing kits are urgently recalled amid fears they give false readings and could put lives at risk.
Patients have been advised to urgently stop using and return specific lots of Accu-Chek Aviva and Accu-Chek Performa test strips due to concerns they may give falsely high or low readings.
The Medicines and Healthcare products Regulatory Agency (MHRA) said it is estimated that more than 260,000 packs have been affected.
It warned the test strips, commonly used by diabetics for blood glucose testing, may give increased strip error messages prior to dosing with blood and in some cases may give falsely high or low readings, which may be hard to detect.
Dan Howarth, head of care at Diabetes UK, said inaccurate readings could mean patients over or under-dose with insulin, which can cause problems with hyper and hypoglycaemia.
If anyone finds that they have test strips from the affected lots, they are advised to seek alternative testing methods and return affected lots to their pharmacy or shop where they will be offered a replacement.
Anyone with concerns about their blood glucose readings should also speak to their doctor or another healthcare professional.
Diabetes testing kits are urgently recalled amid fears they give false readings (stock)
WHY IS IT IMPORTANT FOR DIABETES PATIENTS TO MEASURE THEIR GLUCOSE LEVELS?
Diabetes is a serious life-long condition that occurs when the amount of sugar in the blood is too high because the body can’t use it properly.
Patients have to regular monitor their glucose levels to prevent them from developing any potentially fatal complications.
Type 1 diabetes patients are often recommended to test their blood sugar at least four times a day. For type 2 patients, doctors advise to test twice a day.
Blood glucose levels should be between the ranges of 3.5–5.5mmol/L before meals and less than 8mmol/L, two hours after meals.
Diabetes patients have to regular monitor their glucose levels to prevent them from developing any potentially fatal complications
Hypoglycemia (when blood sugar drops below 4 mmol/L) can occasionally lead to patients falling into comas in severe cases.
However, it most often can be treated through eating or drinking 15-20g of fast acting carbohydrate, such 200ml of Lucozade Energy Original.
Sufferers can tell they are experiencing a hypo when they suddenly feel tired, have difficulty concentrating or feel dizzy.
Type 1 diabetes patients are more likely to experience a hypo, because they rely of the medications they take, including insulin.
Hyperglycemia (when blood sugar is above 11.0 mmol/L two hours after a meal) can also have life-threatening complications.
It happens when the body either has too little insulin, seen in type 1, or it can’t use its supply properly, most often in type 2.
In the short-term, it can lead including ketoacidosis – which causes ketones to be released into the body.
If left untreated, hyperglycemia can lead to long-term complications, such as impotence and amputations of limbs.
Regular exercise can help to lower blood sugar levels over time, and following a healthy diet and proper meal planning can also avoid dangerous spikes.
MHRA said the over-the-counter products affected are Accu-Chek Aviva in packs of 50 strips with lot numbers 497392, 497391, 496915, 496809, 496802 and 496807, and 10 strips with lot numbers 497344 and 497392.
Accu-Chek Performa in packs of 10 strips with lot numbers 476597 and 476646 are also included in the recall.
Accu-Chek Inform II test strips have also been recalled but are supplied in the UK by Roche for professional use only.
John Wilkinson, MHRA director of medical devices, said: ‘It is important people check their test strips and if necessary seek alternatives as soon as possible.
‘If people have any questions about their blood glucose readings when using these test strips and meters they should speak with their doctor or pharmacist.
‘We continue to encourage people to report any issues involving medical devices to the MHRA via our Yellow Card Scheme.’
Mr Howarth added: ‘It is incredibly important that people living with diabetes are able to rely on the technology that is designed to help them manage their blood sugar, so we’d strongly recommend that anyone using these test strips check their batch numbers and get replacement strips accordingly.
‘Inaccurate readings could mean you over or under-dose with insulin, which in the short term can cause problems with hyper and hypoglycaemia.
‘If you’re worried about your readings, we’d recommend speaking to your GP or a pharmacist as soon as possible.’
Source: Read Full Article